Moderate Chronic Obstructive Pulmonary DiseaseNCT03745547
An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects
An observational study of Moderate Chronic Obstructive Pulmonary Disease and Severe Chronic Obstructive Pulmonary Disease, run by Spire, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- Adherence to wearing a Spire wearable health monitor
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 11 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult moderate Chronic Obstructive Pulmonary Disease (COPD) and severe Chronic Obstructive Pulmonary Disease (COPD) as reported by participant
Who may be able to join
- Age ≥18 years old
- Self-reported diagnosis of moderate to severe COPD
- >=1 self-reported COPD-related hospitalization within the previous 12 months
- Currently using an iPhone 6 or newer and willing to install the Spire smartphone app
- Willing to wear Health Tags 80% of each 24 hour period and answer the email-based self-assessments weekly for the study duration
- Willing to provide consent to participate and abide by study protocol for study duration (9 months)
- Must be able to read and understand English
- Access to Wi-Fi at home and at work, for at least 20 hours per day (and smartphone connected to Wi-Fi throughout the study duration)
Who cannot join
- Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, idiopathic pulmonary fibrosis, or chest wall deformities).
- Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
- Pregnant at the time of study or expecting to become pregnant throughout the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD
The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. To achieve this purpose, Spire will collect data from a wearable monitor that participants attach to the participant's clothing, an associated smartphone application, and completion of weekly questions. The wearable monitor and the consumer smartphone application to be used are consumer products and currently available in the market.
This study does not include clinical intervention and no doctors will be involved in this study.
No clinical tests or office visits are included in this study. All data will be collected through an online survey tool and remotely through the wearable sensors.
Read the detailed description
This is an exploratory, observational, non interventional, single-arm, open label, remote pilot study involving up to 150 self-reported COPD participants. Eligible participants will wear the Spire biophysiological health monitors for a period of 9 months while the participants report symptoms on a weekly basis via brief surveys. If and when participants incur a COPD-related exacerbation which results in a medication change after hospitalization or contact with a healthcare provider, participants will report this on the weekly surveys. When this survey is read by a study nurse, the nurse will follow up with the participant by phone to conduct a post-exacerbation phone screening. This data would provide context to inform how to correlate the biosensor-sensed physiological parameters with the exacerbation self-reported data. All study participants will be remotely distributed throughout the United States.
- Conditions
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease
- Being tested
- Adherence to wearing a Spire wearable health monitor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to wearing a Spire wearable health monitorOther
Participants will wear a Spire health monitor every day for 9 months and receive weekly emails with a short survey about the participant's condition and symptoms. If participants fail to respond to this email or Spire detects that a participant is not wearing the monitor, participants will be contacted by a nurse. While participants are wearing the monitor, Spire will make sure the sensors are collecting data but will not review the data in real time. If a participant's monitor stops sending data to Spire for more than 24 hours, the participant will be contacted. If the participant is unreachable for 10 days the participant's emergency contact will be contacted. If neither the participant nor the emergency contact is reachable over 24 days the participant will be removed from the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spire wearable health monitor physiological data collection
To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants
Measured: weekly email surveys and phone calls over a nine month period
Secondary outcomes (1)
Participant adherence
To evaluate the daily adherence to wearing the Spire wearable health monitor in COPD participants
Measured: weekly email surveys and phone calls over a nine month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Nov 2018
- Primary completion10 Apr 2020
- Study completion11 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spire, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ResMed
- Responsible party
- Sponsor
- Investigators
- Neema Moraveji, PhD, Principal investigator, Spire, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745547
- Sponsor's protocol ID
- SP/C/007
- Status last verified
- Jan 2021
- First submitted
- 14 Nov 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD
- ClinicalTrials.gov ID
- NCT03745547
- Acronym / sponsor ID
- SP/C/007
- Conditions
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Spire, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ResMed
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 11 Apr 2020 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. To achieve this purpose, Spire will collect data from a wearable monitor that participants attach to the participant's clothing, an associated smartphone application, and completion of weekly questions. The wearable monitor and the consumer smartphone application to be used are consumer products and currently available in the market.
This study does not include clinical intervention and no doctors will be involved in this study.
No clinical tests or office visits are included in this study. All data will be collected through an online survey tool and remotely through the wearable sensors.
Detailed description
This is an exploratory, observational, non interventional, single-arm, open label, remote pilot study involving up to 150 self-reported COPD participants. Eligible participants will wear the Spire biophysiological health monitors for a period of 9 months while the participants report symptoms on a weekly basis via brief surveys. If and when participants incur a COPD-related exacerbation which results in a medication change after hospitalization or contact with a healthcare provider, participants will report this on the weekly surveys. When this survey is read by a study nurse, the nurse will follow up with the participant by phone to conduct a post-exacerbation phone screening. This data would provide context to inform how to correlate the biosensor-sensed physiological parameters with the exacerbation self-reported data. All study participants will be remotely distributed throughout the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult moderate Chronic Obstructive Pulmonary Disease (COPD) and severe Chronic Obstructive Pulmonary Disease (COPD) as reported by participant
Key inclusion criteria (8 listed)
- Age ≥18 years old
- Self-reported diagnosis of moderate to severe COPD
- >=1 self-reported COPD-related hospitalization within the previous 12 months
- Currently using an iPhone 6 or newer and willing to install the Spire smartphone app
- Willing to wear Health Tags 80% of each 24 hour period and answer the email-based self-assessments weekly for the study duration
Key exclusion criteria (3 listed)
- Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, idiopathic pulmonary fibrosis, or chest wall deformities).
- Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
- Pregnant at the time of study or expecting to become pregnant throughout the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to wearing a Spire wearable health monitorParticipants will wear a Spire health monitor every day for 9 months and receive weekly emails with a short survey about the participant's condition and symptoms. If participants fail to respond to this email or Spire detects that a participant is not wearing the monitor, participants will be contacted by a nurse. While participants are wearing the monitor, Spire will make sure the sensors are collecting data but will not review the data in real time. If a participant's monitor stops sending data to Spire for more than 24 hours, the participant will be contacted. If the participant is unreachable for 10 days the participant's emergency contact will be contacted. If neither the participant nor the emergency contact is reachable over 24 days the participant will be removed from the study. | Other | – |
Primary outcome
Spire wearable health monitor physiological data collection
Time frame: weekly email surveys and phone calls over a nine month period
To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants
1 secondary outcome
Participant adherence
Time frame: weekly email surveys and phone calls over a nine month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No. No IPD will be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neema Moraveji, PhD principal investigator
Spire, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Chronic Obstructive Pulmonary Disease and Severe Chronic Obstructive Pulmonary Disease, run by Spire, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spire wearable health monitor physiological data collection (time frame: weekly email surveys and phone calls over a nine month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.